Kornimate/medical-research-clean huggingface dataset:
human milk: understanding the mechanisms linked to the prevention of obesity and diabetes in children exposed in utero to gestational diabetes

Conditions: Gestational Diabetes

Summary: breastfeeding has been associated with decreased obesity. however, this relationship is not as clear in children who have been exposed to gdm and the mechanisms involved are little known. the overall objective of the project is to study the mechanisms of breastfeeding on the growth of children in women who have had a gdm. more specifically, the project want to compare the macronutrient and hormone composition of breast milk of women with and without gdm. investigators also want to associate the levels of hormones related to satiety and energy metabolism (i.e. endocannabinoids, ghrelin, leptin) in the human milk of women with or without dg and the growth of the child. a total of 60 women (30 with gdm and 30 without gdm) will collect breastmilk at 2 months postpartum.

other data collected: waist circumference, dxa, fasted blood sample, oral glucose tolerance test, breastfeeding habits, food habits, baby's height et weight.

Eligibility criteria:
inclusion criteria: * breastfeeding women exclusion criteria: * type 1 or type 2 diabetes * preterm birth * history of bariatric surgery * multiple births
safety and efficacy of cannabidiol for grade i/ii acute graft versus host disease (gvhd) after allogeneic stem cell transplantation

Conditions: Graft Versus Host Disease

Summary: graft versus host disease (gvhd) is one of the major causes of death in patients undergoing allogeneic hematopoietic stem cell transplantation. despite prophylactic measures, the incidence of acute gvhd is estimated at 40-60% among patients receiving transplants from hla-identical sibling donors, and may even reach 75% in patients receiving hla-matched unrelated transplants. more effective prevention and treatment strategies are needed. the immunomodulatory and anti-inflammatory properties of cannabinoids have been shown in animal models of various inflammatory diseases including multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis. cannabidiol is a major non-psychoactive cannabinoid, which has potent anti-inflammatory and immunosuppressive effects. as such, it may be effective for both prevention and treatment of acute gvhd after allogeneic stem cell transplantation.


Eligibility criteria:
inclusion criteria: 1. patients over 18 years 2. acute gvhd grade i/ii 3. no history of psychosis 4. signed informed concent exclusion criteria: 1. acute gvhd grade \> ii 2. history of psychosis 3. history of asthma

Keywords: cannabidiol gvhd allogeneic transplantation
repeatability and reproducibility of the iolmaster 700 vers 1.70 and agreement with iolmaster 700 vers. 1.50 and pentacam

Conditions: Cornea

Summary: the objectives of this study are to determine the agreement of measurements between the iolmaster 700 sw vers. 1.70 and iolmaster 700 sw vers. 1.50 and pentacam, as well as to evaluate the repeatability and reproducibility of the iolmaster 700 sw vers 1.70. the following parameters will be evaluated for total keratometry, (tk) and posterior corneal surface (pcs): * cylinder (cyl), axis (a) * spherical equivalent (se) specific objectives: 1. to compare the agreement of se between iolmaster 700 sw vers. 1.70 and iolmaster 700 sw vers. 1.50 (carl zeiss meditec ag, jena, germany) 2. to compare the agreement of cylinder magnitude and axis between iolmaster 700 sw version 1.70 and pentacam 3. to evaluate the repeatability and reproducibility of the iolmaster 700 sw vers. 1.70 for all measurement parameters listed above


Eligibility criteria:
inclusion criteria: 1. male or female 22 years of age and older. 2. no history of rigid contact lens wear for at least 2 weeks. soft lenses, if worn, should be removed at least one hour prior to the measurement. 3. able and willing to make the required study visits. 4. able and willing to give consent and follow study instructions. 5. group 1: normal eyes with best-corrected visual acuity of 20/20 or better, and lens opacities of 1.0 or less in the study eye using the locs iii system, and no prior laser vision correction. 6. group 2: cataract in the study eye greater than grade 1 using the locs iii system for one or more: nuclear opacity, nuclear color, cortical opacity, or psc. 7. group 3: history of laser vision correction (lvc). exclusion criteria: 1. previous intraocular surgery other than laser vision correction in the study eye. 2. previous corneal surgery other than laser vision correction in the study eye. 3. presence of any corneal or retinal abnormality on slit lamp examination in the study eye. 4. corneal cylinder \< 0.75d measured with a iolmaster. 5. active ocular infection or inflammation. 6. poor tear film/insufficient corneal reflex. 7. best corrected visual acuity worse than 20/200 in the study eye. 8. physical inability to be positioned at the slit-lamp biomicroscope or study devices (e.g. torticollis, head tremor, etc.). 9. insufficient eyelid opening or eyelashes which partially conceal alignment or keratometry reflections and prevent capture of all measurements. 10. inability to fixate (e.g. due to nystagmus, amblyopia or ocular disease, such as macular degeneration). 11. rigid contact lens wear during past two weeks. 12. principal investigator's determination that the subject is not suitable due to other medical condition (reasons to be listed on ecrfs).
protocol for the lipid registry of africa

Conditions: Acute Coronary Syndrome; Atherosclerosis

Summary: the lipid registry of africa (lipra) aims to understand why some individuals in africa experience heart issues at a younger age than others. the study investigates factors causing heart problems in younger adults, particularly acute coronary syndrome (acs). acute coronary syndrome (acs) includes various heart conditions like unstable angina and heart attacks. researchers from multiple african countries collaborate to gather information from hospitals across the region. they focus on patients under 55 years (men) or 65 years (women) with heart issues. additionally, the study wants to compare different groups-men and women, urban and rural residents-to see if there are specific differences in how heart problems develop among them.


Eligibility criteria:
inclusion criteria: * individuals diagnosed with premature acute coronary syndrome (acs) within the defined age range (≤55 years in men and ≤65 years in women). * patients admitted to designated cardiac facilities in africa (urban and rural). * diagnosed cases of st-elevation myocardial infarction (stemi) or non-st-elevation myocardial infarction/unstable angina pectoris (nstemi/uap) based on predetermined criteria including symptoms, electrocardiogram (ecg) alterations, and biomarker levels. * patients exhibiting an increase (above the 95th percentile) or decrease in serum troponin levels as per admission standards. exclusion criteria: * individuals outside the defined age range for premature acute coronary syndrome (acs) diagnosis. * patients not admitted to designated cardiac facilities in africa. * diagnosed cases not meeting the specified criteria for acute coronary syndrome (acs) subtypes (stemi, nstemi/uap) based on symptoms, electrocardiogram (ecg), and biomarker levels.

Keywords: lipid registry of africa acute coronary syndrome cardiovascular risk factors multinational study
study of a new technique for imaging pancreatic cancer

Conditions: Pancreatic Cancer; Tumors That Express CA19-9

Summary: the purpose of this study is to see how well the experimental imaging agent 89zr-dfo-humab-5b1 attaches to pancreatic tumors, and to find out whether pet/ct scans done with this imaging agent produce better images of cancer.


Eligibility criteria:
inclusion criteria: part i : escalation, expansion, re-entry cohorts: * histologically confirmed, locally-advanced, or metastatic pancreatic ductal adenocarcinoma (pdac) or other malignancies known to express ca19-9 positive malignancies part ii: pre-surgery cohort only: * patients with biopsy-proven or high suspicion on imaging for pancreatic ductal adenocarcinoma (pdac) (stage t2 and t3) * patients scheduled referred to surgery or biopsy as standard of care for their pancreatic adenocarcinoma or * patients with intraductal papillary mucinous neoplasm (ipmn) referred to surgery or biopsy as standard of care. the suspicion for pancreatic carcinoma and decision for surgery or biopsy will be based on review of imaging and clinical findings in the disease management team discussion including surgeon and radiologist. part i and ii: * signed, informed consent * age 18 or more years * at least one lesion by ct or mri ≥ 2 cm, unless determine otherwise for pre-surgery cohort subjects * ca19-9 serum level: * for part i: \>uln or ca19-9 positive biopsy (optional); * for part ii ( presurgical cohort): ca19-9 serum level (normal or high levels are allowed) or ca19-9 positive biopsy (optional) * ecog performance status of 0 to 2 * adequate laboratory parameters including: * absolute neutrophil count (anc) ≥1.5 x 10\^9/l * hemoglobin ≥ 9.0 g/dl (in the absence of red blood cell transfusions in the prior 14 days) * platelet count \>75,000/ mm\^3 * ast/sgot, alt/sgpt ≤2.5 x uln, unless liver metastases are clearly present, then ≤5.0 x uln * total bilirubin ≤1.5x the upper limit of normal unless considered due to gilbert's syndrome in which case, ≤3x the upper limit of normal * creatinine (serum or plasma) ≤ 1.5 x uln or egfr\>50 ml/min part i: escalation, expansion, re-entry cohorts: * willingness to participate in collection of pharmacokinetic samples exclusion criteria: * active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy * major surgery other than diagnostic surgery within 4 weeks of study day 1 * history of anaphylactic reaction to human, or humanized, antibody * other on-going cancer therapy or investigational agents (except mvt-5873) * known history of hiv * pregnant or currently breast-feeding * psychiatric illness/social situations that would interfere with compliance with study requirements * prior entry onto this protocol 3 or more times (e.g., subjects may enter this protocol and be imaged up to 3 times)

Keywords: 89zr-dfo-humab-5b1 (mvt-2163) imaging mvt-5873 20-342
a study of mavacamten in obstructive hypertrophic cardiomyopathy

Conditions: Cardiomyopathy, Hypertrophic Obstructive

Summary: the purpose of this study is to evaluate the effectiveness, safety, and tolerability of a 30-week course of mavacamten and the long-term effects of mavacamten in japanese participants with symptomatic obstructive hypertrophic cardiomyopathy (hcm).


Eligibility criteria:
inclusion criteria: * age 18 and greater, body weight ≥ 35kg * has adequate acoustic windows to enable accurate transthoracic echocardiograms (ttes) * diagnosed with obstructive hypertrophic cardiomyopathy consistent with current american college of cardiology foundation/american heart association, european society of cardiology, and japanese circulation society guidelines * has documented left ventricular ejection fraction (lvef) ≥60% nyha class ii or iii exclusion criteria: * known infiltrative or storage disorder causing cardiac hypertrophy that mimics ohcm, such as fabry disease, amyloidosis, or noonan syndrome with lv hypertrophy * history of syncope or sustained ventricular tachyarrhythmia with exercise within 6 months prior to screening * history of resuscitated sudden cardiac arrest (at any time) or known history of appropriate implantable cardioverter defibrillator (icd) discharge for life-threatening ventricular arrhythmia within 6 months prior to screening * paroxysmal atrial fibrillation with atrial fibrillation present at the time of screening. * persistent or permanent atrial fibrillation not on anticoagulation for at least 4 weeks prior to screening and/or not adequately rate controlled within 6 months prior to screening * treatment (within 14 days prior to screening) or planned treatment during the study with cibenzoline, disopyramide or ranolazine * treatment (within 14 days prior to screening) or planned treatment during the study with a combination of beta blockers and verapamil or a combination of beta blockers and diltiazem * has been successfully treated with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation \[asa\]) within 6 months prior to screening or plans to have either of these treatments during the study * icd placement within 2 months prior to screening or planned icd placement during the study * has a history or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to participant safety or interfere with the study evaluation procedures, or completion * prior treatment with cardiotoxic agents such as doxorubicin or similar other protocol-defined inclusion/exclusion criteria apply

Keywords: mavacamten obstructive hypertrophic cardiomyopathy (hcm)
citrulline and protein metabolism in the malnourished elderly people

Conditions: Metabolism; Elderly

Summary: the aim of this study is to evaluate the effects of a supplementation of citrulline for three weeks in elderly malnourished and hospitalised subjects on muscle protein synthesis.

malnutrition in the elderly causes an important public health problem because their response to re nutrition is highly decreased. several experimental studies have shown that an amino acid named citrulline could avoid this, by restoring protein synthesis. the treated group will receive each morning for three weeks a supplementation of 10 g of citrulline and the control group, non essential amino acids in iso-nitrogenous quantity to the 10g of citrulline. during the three weeks of supplementation, clinical tolerance and physical exercise will be evaluated regularly. on the 21st day, whole body protein synthesis rate in the post-absorptive state will be measured by the isotopic dilution of l-leucine (1-13c expressed in g / kg of lean mass / 24h) as well as other parameters of the protein turn-over in the post-absorptive and post-prandial state.

Eligibility criteria:
inclusion criteria: * elderly hospitalised in geriatric medicine or in following care and rehabilitation, moderately malnourished * aged more than 70 years * recent moderate undernutrition (30 g/l \ 30 g/l) * ingesta of at least 20 kcal / kg / d and 0,8 g / kg / d of proteins exclusion criteria: * hospitalisation \< 21d * c reactive protein (crp) \> 50 mg / l * end-stage cardiac insufficiency * severe digestive incapacity * renal insufficiency (creatinine clearance \< 30 ml / mn) * respiratory failure * mms \< 18 * uncontrolled acute or chronic infectious pathology (hiv, tuberculosis) * corticoids treatment * evolutionary neoplasia * palliative phase of severe pathology * mental mini score status of folstein (mms) \< 8 * parenteral nutrition * active chronic hepatitis or cirrhosis * participation in another trial

Keywords: citrulline protein-energy malnutrition aged protein biosynthesis amino acid
coronary bypass and artotic leaflet surgery : heparin low dose vs full dose

Conditions: Cardiac Surgery; Extracorporeal Circulation

Summary: the purpose of this study is to demonstrate superiority on postoperative bleeding from the use of a heparin half dose compared to a conventional dose, under mini-extra corporeal circulation, without increased risk to the patient.

usually management of conventional extra corporeal circulation takes place under a loading heparin dose of 300 iu / kg to achieve an act (activating clotting time) target more than 400 seconds. this empirical approach based on patient weight date from the 1960's and does not take into account materials improvement and different individual sensitivities; several studies have demonstrated than a result at least as effective could be obtained with heparin lower doses, and without increasing thromboembolic morbid events for patients. patients are randomly assigned into one of 2 groups one day before surgery. first group receive unfractionated heparin conventional dose during the mecc, second group receive half of the conventional dose. all surgery is performed by the same team and using same equipment. regular blood tests are carried out before, during and after surgery. blood loss, transfusion needs, rhythm disorders, stay duration in intensive care and total hospitalization length is finally reported. the follow-up period through the 30th postoperative day.

Eligibility criteria:
inclusion criteria: * single or multiple coronary bypass * written and informed consent * repair or replacement of artic leaflet * platelet suppressive agents stopped since at least 7 days * anticoagulants stopped since at least 3 days exclusion criteria: * thoracic surgery antecedent * asa 4 * carotid stenosis \> 75% * hb \< 10,5 g/l * chronic hepatic failure * thromboembolic antecedent

Keywords: heparin low dose inflammation blood loss
a study to evaluate the efficacy of cjh1 (clr4001) in parkinson's disease

Conditions: Parkinson's Disease

Summary: the purpose of this study is to assess the ability of cjh1 to increase the sensitivity of dopamine receptors and thereby reduce symptoms of parkinson's disease.


Eligibility criteria:
inclusion criteria: * patient's with parkinson's disease exclusion criteria: * contraindications to study medication

Keywords: novel treatment parkinson's disease
pulmonary rehabilitation in end-stage liver disease

Conditions: End Stage Liver Disease

Summary: the purpose of this study is to assess the impact of exercise on sarcopenia and frailty. the exercise that will be performed in this study will include either pulmonary rehabilitation or a formal home based video strengthening program

participants will be randomized into two groups. the pulmonary rehabilitation group will undergo exercise under a supervised setting for a total duration of 12 weeks. patients will perform endurance (treadmill or cycle ergometer), strength (weight resistance) and flexibility training twice a week for a period of an hour per session. exercises will be supervised by physiotherapists or exercise physiologists. compliance and performance will be monitored by the trainer. they will receive a pedometer for home use. the home based program group will perform rest for 10 minutes daily, increasing to 20 minutes daily, after the second week, in their home environment. the total duration of the intervention will be 12 weeks. patients will be provided with pedometers, rest video and binder, with instructions on how to perform exercises, and resistance bands.

Eligibility criteria:
inclusion criteria: * wait listed for liver transplantation with poor 6 mwt exclusion criteria: * age \< 18 years * recent hospitalization (within 14 days) due to decompensation, variceal bleeding in the previous 1 month * large esophageal varices without primary prophylaxis * active excessive alcohol intake (in the previous 3 months) * current overt uncontrolled hepatic encephalopathy * hepatopulmonary syndrome with uncontrolled hypoxia * portopulmonary hypertension * inability to perform exercise * marked symptomatic comorbidities (cardiac, pulmonary, renal).

Keywords: frailty sarcopenia pulmonary rehabilitation
long-term efficacy and safety study of gv-971

Conditions: Alzheimer Disease

Summary: sodium oligomannate capsules (gv-971) has been approved for treatment of mild to moderate alzheimer's disease and improving the cognitive function of patients. this study plans to observe, in the clinical patients, the long-term efficacy and safety of gv-971, as well as the changes in blood and gut microbiota biomarkers after treatment, to validate the mechanism of action of gv-971, in order to better guide the rational use of drug in clinical practice.


Eligibility criteria:
inclusion criteria: 1. aged 50 to 85 years (inclusive), with no restriction on gender; 2. patients who met criteria for "probable ad" by national institute on aging and alzheimer's association (nia-aa) diagnostic criteria; 3. patients with mild to moderate ad as characterized by mini-mental state examination (mmse) scores between 11 and 26, inclusive; 4. patients who have received at least primary education and have capacity to complete the measurement of cognition and other tests as specified in the protocol; 5. patients receiving gv-971 treatment prescribed by clinicians; 6. sign the informed consent form. exclusion criteria: 1. patients who have received gv-971 treatment within 6 months prior to screening; 2. patients who may be allergic to sodium oligomannate capsules as judged by the investigator; 3. female participants who are pregnant or lactating; 4. patients who cannot cooperate to complete the follow-up inquiries; 5. any other diseases or conditions that are inappropriate to participate in this clinical trial in the opinion of the investigator.
forced oscillation versus spirometry in diagnosing post pulmonary transplant bronchiolitis obliterans syndrome

Conditions: Bronchiolitis Obliterans Syndrome

Summary: a study to evaluate the role of forced oscillation in precocious diagnosis of bronchiolitis obliterans syndrome in patients with pulmonary transplant (time difference in detecting distal airways functional impairment by forced oscillation and the standard technique using spirometry).


Eligibility criteria:
inclusion criteria: * patients of more than 18 year-old. * patients with cardiopulmonary transplant or bilateral lung transplant. * clinically stable patients exclusion criteria: * patients already diagnosed with bronchiolitis obliterans. * respiratory infection. * acute graft rejection. * mechanical complications (bronchial dehiscence, pneumothorax, pleural effusion). * iatrogenic pneumopathy. * inability to perform respiratory function test.
comparison of removing and non-removing patellofemoral joint osteophytes following medial unicompartment knee arthroplasty

Conditions: Anterior Knee Pain

Summary: background: anterior knee pain (akp) is a challenge following unicompartmental knee arthroplasty (uka). some surgeons remove patellofemoral joint (pfj) osteophytes to reduce osteophyte impingement and akp. however, there is evidence that pfj osteophytes compensate for knee osteoarthritis (oa) by increasing and improving stability and increase contract surface area in knee osteoarthritis. moreover, when pfj osteophytes are not removed, some studies report good clinical outcomes. the issue of removing or leaving pfj osteophytes is controversial. the objective of this study was to compare akp following mobile bearing uka after removing or leaving pfj osteophytes. methods: the prospective non-randomized study included 89 isolated medial osteoarthritis (oa) of knee. they were classified into 2 groups. group (gp)1 was removing pfj osteophytes; consists of 44 knees. gp2 was non-removing pfj osteophytes: consists of 45 knees. the patients were follow up and recorded incidence of akp and vas for akp at 6 weeks, 3months, 6 months, 1 year and 2 years. no patients were lost to follow up. the patellar tilt and shift were measured at 6 weeks, 3months, 6months, 1year and 2 years via skyline view radiography. the knee society scores, oxford knee score, knee injury and osteoarthritis outcome score, forgotten joint score and kujala scale also were recorede at 6 weeks, 3months, 6months, 1 year and 2 years.

removing and non-removing osteophyte at patellofemoral joint is controversial topic. the osteophyte may help to reduce load and improve stability of patellofemoral joint. therefore, the purpose of this study is to compared anterior knee pain between removing and non-removing osteophyte at patellofemoral joint following medial mobile bearing unicompartmental knee arthroplasty

Eligibility criteria:
inclusion criteria: * age \> 42 years old * range of motion \> 90 degrees * flexion contracture\< 15 degrees * normal function of anterior cruciate ligament exclusion criteria: * spontaneous osteonecrosis of the knee * inflammatory joinr arthritis * full thickness cartilage loss at lateral compartment

Keywords: patellofemoral osteophyte anteromedial osteoarthritis knee mobile bearing uka patellofemoral pain